On May 28, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported enrollment of the first patients in SIgnatera-Guided iNterventionAL (SIGNAL)-ER 101, a prospective, single-arm, multi-center study evaluating Signatera MRD-guided de-escalation in early-stage breast cancer.

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The current standard of care recommends two or three years of an adjuvant CDK4/6 inhibitor in combination with endocrine therapy for patients with intermediate-risk, hormone receptor (HR) positive, HER2 negative, early stage breast cancer. This is despite the fact that only ~3% of eligible patients derive benefit, over 60% of patients experience serious adverse events,1-2 and the U.S. retail costs can be over $400,000 for a full course of treatment. Meanwhile, data presented at SABCS 2025 from the PALLAS trial show that HR+ breast cancer patients who tested MRD-negative with Signatera had excellent long-term outcomes, with >95% distant recurrence-free interval at 5 years. This suggests that MRD-negative patients can safely defer CDK4/6 inhibition with no impact to clinical outcomes, with the provision that it be added if and when MRD is detected on serial testing using a TOMR (Treatment on MRD) approach.

SIGNAL-ER 101 plans to enroll approximately 725 patients across 50 sites in the United States. Patients who test MRD-positive will receive endocrine therapy plus CDK4/6 inhibitors, while those who test MRD-negative (the vast majority of patients) will receive endocrine therapy alone with quarterly Signatera monitoring. Patients who become MRD-positive during surveillance will be eligible to initiate CDK4/6 inhibition at that time, consistent with the TOMR approach.

"Many women with this type and stage of breast cancer are overtreated, which can have a profound impact on their quality of life," said Minetta Liu, M.D., chief medical officer, oncology and early cancer detection at Natera. "SIGNAL-ER 101 is a key part of our evidence generation roadmap, to support Signatera-guided treatment optimization without compromising the survival benefit from CDK4/6 inhibitors. This approach also allows patients to get the most effective treatment when Signatera shows it is necessary."

SIGNAL-ER 101 is the first in a series of innovative Natera-sponsored SIGNAL trials across multiple cancer types, designed to demonstrate that MRD-negative patients may be able to delay or defer treatment. There are many instances of overtreatment in cancer. This concept has already been studied in the IMvigor011 trial where MRD-negative patients with muscle-invasive bladder cancer achieved 97% overall survival at 2 years without any adjuvant therapy, and in the GALAXY and CALGB/SWOG 80702 trials, where MRD-negative patients with colorectal cancer saw no clinical benefit from adjuvant chemotherapy and celecoxib, respectively.

(Press release, Natera, MAY 28, 2026, View Source [SID1234666174])

On May 28, 2026 Imugene Limited (ASX: IMU) a clinical-stage immunooncology company, reported the enrolment of first patient into the BTK inhibitor combination cohort of its ongoing Phase 1b basket study of azer-cel. Azer-cel is an offthe-shelf, allogeneic CAR T cell therapy being evaluated across multiple advanced blood cancers with significant unmet medical need.

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Patients in this third cohort will be treated with azer-cel in combination with a BTKi with the objective of evaluating safety and preliminary efficacy. These patients have previously failed BTKi therapy, an established standard of care therapy across multiple B-cell malignancies. including follicular lymphoma (FL), chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). Enrolment is ongoing across ten US and five Australian sites.

Despite their efficacy as front-line and subsequent treatments, many patients ultimately develop resistance or intolerance to BTKi therapy, representing a significant area of unmet medical need. The combination of azer-cel with a BTKi aims to explore whether concurrent dosing may enhance the activity of azer-cel and BTKi in this setting.

The addition of the BTKi combination cohort expands the clinical scope of the azer-cel program and may support further partnering and collaboration opportunities. By broadening the range of eligible B-cell malignancies in the Phase 1b study, the Company is better positioned to prioritise indications where azer-cel demonstrates the strongest clinical potential, supporting a disciplined and capital-efficient development strategy. The global BTKi market was valued at approximately US$12.0 billion in 2025.

Chief Executive Officer Leslie Chong said "The enrolment of first patients into the BTKi combination cohort is a meaningful step in expanding the clinical scope of the azer-cel program. BTKi-relapsed patients represent a significant population with limited options, and we believe the concurrent combination approach has the potential to address this unmet need.

We look forward to reporting safety and preliminary efficacy data as patients become evaluable, and to continuing to build the evidence base for azer-cel across B-cell malignancies."

Further updates will be provided as patients become evaluable and data matures.

About the Phase 1b azer-cel trial

The azer-cel allogeneic CAR T trial is an ongoing, open-label, multi-centre Phase 1b clinical trial in the U.S. and Australia, for CAR T relapsed patients and CAR T naïve patients diagnosed with a broad range of Non-Hodgkins lymphomas including follicular lymphoma (FL), chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), marginal zone lymphoma (MZL), Waldenstrom macroglobulinemia (WM), and mantle cell lymphoma (MCL). The trial has recently expanded into a BTKi combination cohort, for patients with a range of B-cell malignancies who have previously failed BTKi therapy. Treatment with azer-cel, lymphodepletion (LD) and IL-2 is showing promising results with evidence of meaningful clinical activity, and durability of response. Additionally, the safety profile is manageable and generally well tolerated.

(Press release, Imugene, MAY 28, 2026, View Source [SID1234666111])

On May 28, 2026 CRISPR Therapeutics (Nasdaq: CRSP) reported that members of its senior management team are scheduled to participate in the following investor conferences in June.

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Jefferies Global Healthcare Conference
Date: Wednesday, June 3, 2026
Time: 9:55 a.m. ET

William Blair’s 46th Annual Growth Stock Conference
Date: Wednesday, June 3, 2026
Time: 4:40 p.m. CT

Goldman Sach’s 47th Annual Global Healthcare Conference
Date: Tuesday, June 9, 2026
Time: 2:40 p.m. ET

A live webcast will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcasts will be archived on the Company’s website for 14 days following the presentation.

(Press release, CRISPR Therapeutics, MAY 28, 2026, View Source [SID1234666143])

On May 28, 2026 Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, reported updated positive Phase 2 results of spevatamig (PT886) in combination with chemotherapy in frontline (1L) treatment of metastatic pancreatic ductal adenocarcinoma (PDAC) for the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2026 . The full poster presentation will be held on Saturday, May 30 between 9am-12pm CDT during the Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Session (Abstract #4192, Poster #175).

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The data show spevatamig, an anti-CLDN18.2/CD47 bsAb, in combination with chemotherapy, has the potential to be an effective 1L treatment in patients with metastatic PDAC (mPDAC).

The design of spevatamig with an optimized anti-CD47 arm mitigates hematological toxicity and improves GI tolerability, as evidenced by the results of the spevatamig monotherapy and combination therapy studies where >190 patients have been dosed globally.

Spevatamig + GnP combination is well tolerated in 1L patients with mPDAC, with no significant additive toxicity to GnP.

2 mg/kg QW spevatamig + GnP showed promising efficacy (52.4% ORR, 90.5% DCR) when compared with the GnP arm in pivotal trials in 1L mPDAC; importantly, more than 90% of patients at this dose level had de novo metastatic disease, consistent with the baseline characteristics of the patient populations in pivotal Phase 3 trials.

Median progression-free survival (mPFS) was 7.3 months, and median overall survival (mOS) was 14.7 months in US patients, where the median follow up time is 14.7 months.

The efficacy data for 3 mg/kg spevatamig + GnP is still maturing. 3 mg/kg has the potential to be the dose level for a Phase 3 registrational study.

Overall, the data support further development of spevatamig + GnP in a randomized Phase 3 trial in patients with 1L mPDAC.
Spevatamig is an innate immunity enhancer (I2E), an emerging class of immuno-oncology (IO) agents. Unlike immune checkpoint inhibitors (ICIs) (also known as anti-PD1/anti-PD-L1 drugs) which activate T cells to kill cancer cells, I2Es activate macrophages and dendritic cells to recognize and destroy cancer cells, providing an alternative mechanism to leverage the immune system to attack tumors, especially the so-called "cold tumors" that do not respond to ICIs.

"We are pleased to see the positive results at the first dose level of spevatamig in the 1L PDAC study. This result is significant because PDAC is considered a ‘cold tumor’ to ICIs. Now we have the opportunity to target PDAC with a new class of immunotherapy," said Ming Wang, PhD, MBA, Founder and CEO of Phanes. "The enrollment at the 3 mg/kg dose level is progressing rapidly and we hope to see efficacy data in the second half of 2026. We could be Phase 3 ready shortly after that. Our goal is to advance this exciting I2E aggressively and deliver an innovative immunotherapy for patients with mPDAC."

ABOUT SPEVATAMIG

Spevatamig is a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47. It was granted orphan drug designation (ODD) for the treatment of pancreatic cancer by the FDA in 2022 and was granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma in 2024. In 2023, Phanes entered into a clinical collaboration agreement with Merck (known as MSD outside the US and Canada) to study spevatamig in combination with pembrolizumab.

Phanes is conducting clinical trials with spevatamig in multiple cancer indications, including a Phase 2 study evaluating the efficacy of spevatamig in combination with chemotherapy in first-line PDAC patients. Spevatamig is a novel immunotherapy which has the potential to become the first innate immunity enhancer (I2E) for a solid tumor indication and is combinable with various anti-cancer therapies.

(Press release, Phanes Therapeutics, MAY 28, 2026, View Source [SID1234666159])

On May 28, 2026 Molecular Targeting Technologies, Inc. (MTTI) reported the clinical findings of the Next-Generation PRRT, ¹⁷⁷Lu-DOTA-EB-TATE to treat GEP-NET Patients. The Phase 1 dose-escalation and dosimetry study will be presented at the 2026 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, taking place May 29–June 3, 2026, in Los Angeles, California.

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Neuroendocrine tumors (NETs) are often detected late, limiting curative treatments and requiring systemic therapies like Peptide Receptor Radionuclide Therapy (PRRT). While 177Lu-DOTATATE has demonstrated efficacy, its rapid clearance limits tumor radiation delivery and may increase renal toxicity risk.

"Our Clinical findings suggest that EBTATE may achieve meaningful clinical responses after only two treatment cycles while delivering approximately 12.5% of the cumulative radioactivity required for standard PRRT," said Chris Pak, Chairman and Chief Executive Officer of MTTI. "If validated in larger studies, EBTATE could represent a transformative advance in radiopharmaceutical therapy, shortening treatment duration, reducing radiation exposure, and enabling physicians to evaluate efficacy much earlier than is possible today."

"EBTATE achieved substantially higher tumor uptake and prolonged retention than conventional ¹⁷⁷Lu-DOTATATE while maintaining a favorable safety profile, with no kidney toxicity observed for one year follow-up," said Lisa Bodei, MD, PhD, a nuclear medicine physician at Memorial Sloan Kettering Cancer Center. "The ability to deliver greater tumor radiation with significantly less administered radioactivity positions EBTATE as a potentially transformative PRRT. These data also support the possibility of a streamlined two-cycle regimen, enabling earlier evaluation of treatment efficacy."

The presentation entitled, "Next-Generation PRRT" by Dr. Bodei (poster # 261874). The poster has also been selected for a 10-minute oral presentation during the 2026 Patient Education Day NETS Program Schedule (View Source), on 5/31/26 during the SNMMI meeting.

MTTI will present its proprietary Evans Blue (EB) albumin-binding technology platform at Booth #1758 during the SNMMI Annual Meeting, featuring clinical data from 81 GEP-NET patients and compelling preclinical results.

MTTI’s EB technology enhances tumor targeting through reversible albumin binding, delivering up to 26-fold greater tumor retention in preclinical models and approximately eight-fold higher tumor uptake in patients compared with conventional DOTA-TATE. These findings position the platform as a potentially transformative approach for next-generation radiopharmaceuticals, with the potential to improve efficacy, expand therapeutic opportunities, and create significant strategic value.

(Press release, Molecular Targeting Technologies, MAY 28, 2026, View Source [SID1234666175])